LPB · Cardiac Ablation Percutaneous Catheter
· Class 3
Overview
| Product Code | LPB |
|---|---|
| Device Name | Cardiac Ablation Percutaneous Catheter |
| Device Class | Class 3 |
| Review Panel |
Identification
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240014 | MAGiC Ablation Catheter | Stereotaxis, Inc. | Jan 5, 2026 | APPR |
| P050029 | HELIOS II ABLATION CATHETER | Stereotaxis, Inc. | Oct 10, 2008 | APPR |
| P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | Biosense Webster, Inc. | Aug 11, 2006 | APPR |
| P040014 | IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR | Irvine Biomedical, Inc. | Jan 14, 2005 | APPR |
| P020045 | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM | Medtronic Cryocath, LP | Apr 17, 2003 | APPR |
| P000020 | STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE | Boston Scientific Corp | Nov 29, 2000 | APWD |
| P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | Biosense Webster, Inc. | May 31, 2000 | APPR |
| P990054 | CHILLI COOLED ABLATION SYSTEM | Boston Scientific Corp | Mar 17, 2000 | APWD |
| P960016 | LIVEWIRE(R) CARDIAC ABLATION SYSTEM | St Jude Medical | May 4, 1999 | APPR |
| P980003 | CHILLI COOLED RF ABLATION SYSTEM | Boston Scientific Corp | Feb 2, 1999 | APWD |
| P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | Biosense Webster, Inc. | Sep 30, 1997 | APPR |
| P930029 | ATAKR(TM) RFCA SYSTEM | Medtronic, Inc. | Feb 9, 1995 | APPR |
| P920047 | EPT-1000 CARDIAC ABLATION SYSTEM | Boston Scientific Corp | Oct 28, 1994 | APPR |
Top Applicants
- Boston Scientific Corp — 4 clearances
- Biosense Webster, Inc. — 3 clearances
- Stereotaxis, Inc. — 2 clearances
- Irvine Biomedical, Inc. — 1 clearance
- Medtronic Cryocath, LP — 1 clearance
